PsoriasisNCT01262534
A Study to Assess the Clinical Profile of Patients in Spain With Moderate to Severe Psoriasis.
An observational study of Psoriasis, run by Janssen-Cilag, S.A..
Trial summary
The purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Clinical profile of patients, Patient Preferences about treatment and Quality of Life
- How many people
- 1,042 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from hospital sites and out-patient dermatology clinics will participate under the conditions of standard clinical practice
Who may be able to join
- Patient over 18 years of age
- Diagnosed with psoriasis at least 6 months before the visit
- Diagnosed with moderate to severe psoriasis
- Who have been treated or not for moderate to severe psoriasis
- For whom the medical history dating back at least 6 months can be accessed
- the patient's legal representative has signed informed consent, stating that the patient understands the study purpose and requirements and grants the patient consent to participate in the study
Who cannot join
- Patient diagnosed with mild psoriasis according to the dermatologist or with a skin disease other than psoriasis
- With any type of difficulty understanding the questions in the DLQI, SF-36 and PBI questionnaires
- Who and/or whose legal representative refuses to grant written, informed consent to participate in the study
About this study
Official title: Observational Epidemiological Registry to Assess the Clinical Profile in Patients With Moderate to Severe Psoriasis in Spain
The purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease, etc.) and its correlation to the patients' quality of life. The secondary objectives are to describe the demographic characteristics and habits of the patient, to evaluate the clinical characteristics of the disease, and to describe the diagnostic and therapeutic procedures being used in standard clinical practice and the patients' expectations for these therapies.
Read the detailed description
This is an epidemiological, non-interventional, multi-centre, cross-sectional, retrospective, observational study to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The data for each patient will be recorded only once, in one visit. During this visit the specialist will ask the patient a series of questions to describe the existence or absence of a number of conditions and their associated treatments, to record the characteristics of psoriasis experienced by the patient and the type of associated treatment. Not applicable
- Conditions
- Psoriasis
- Being tested
- Clinical profile of patients, Patient Preferences about treatment, Quality of Life
- Keywords
- Psoriasis, comorbidities, associated treatment, quality of life
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical profile of patientsOther
Comorbidities and associated type of treatments will be collected.
Patient Preferences about treatmentOther
Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.
Quality of LifeOther
The Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire, to analyze the overall quality of life of patients, and Dermatology Life Quality Index (DLQI), to analyze the quality of life of patients, in dermatological terms).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Clinical profile of patients Comorbidities and associated type of treatments will be collected. Receives: Other: Clinical profile of patients | |
| 2 | Quality of Life The Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire to analyze the overall quality of life of patients and Dermatology Life Quality Index (DLQI) to analyze the quality of life of patients in dermatological terms). Receives: Other: Quality of Life | |
| 3 | Patient Preferences about treatment Patient Benefit Index (PBI) for treatment to record patient preferences regarding psoriasis treatment. Receives: Other: Patient Preferences about treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262534
- Sponsor's protocol ID
- CR017545
- Other IDs
- CNTO1275PSO4013
- Status last verified
- May 2013
- First submitted
- 16 Dec 2010
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Epidemiological Registry to Assess the Clinical Profile in Patients With Moderate to Severe Psoriasis in Spain
- ClinicalTrials.gov ID
- NCT01262534
- Acronym / sponsor ID
- CR017545
- Conditions
- Psoriasis
- Keywords
- Psoriasis, comorbidities, associated treatment, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease, etc.) and its correlation to the patients' quality of life. The secondary objectives are to describe the demographic characteristics and habits of the patient, to evaluate the clinical characteristics of the disease, and to describe the diagnostic and therapeutic procedures being used in standard clinical practice and the patients' expectations for these therapies.
Detailed description
This is an epidemiological, non-interventional, multi-centre, cross-sectional, retrospective, observational study to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The data for each patient will be recorded only once, in one visit. During this visit the specialist will ask the patient a series of questions to describe the existence or absence of a number of conditions and their associated treatments, to record the characteristics of psoriasis experienced by the patient and the type of associated treatment. Not applicable
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Clinical profile of patientsClinical profile of patients Comorbidities and associated type of treatments will be collected. |
| 2 | – | Other: Quality of LifeQuality of Life The Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire to analyze the overall quality of life of patients and Dermatology Life Quality Index (DLQI) to analyze the quality of life of patients in dermatological terms). |
| 3 | – | Other: Patient Preferences about treatmentPatient Preferences about treatment Patient Benefit Index (PBI) for treatment to record patient preferences regarding psoriasis treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from hospital sites and out-patient dermatology clinics will participate under the conditions of standard clinical practice
Key inclusion criteria (6 listed)
- Patient over 18 years of age
- Diagnosed with psoriasis at least 6 months before the visit
- Diagnosed with moderate to severe psoriasis
- Who have been treated or not for moderate to severe psoriasis
- For whom the medical history dating back at least 6 months can be accessed
Key exclusion criteria (3 listed)
- Patient diagnosed with mild psoriasis according to the dermatologist or with a skin disease other than psoriasis
- With any type of difficulty understanding the questions in the DLQI, SF-36 and PBI questionnaires
- Who and/or whose legal representative refuses to grant written, informed consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical profile of patientsComorbidities and associated type of treatments will be collected. | Other | 1 |
| Patient Preferences about treatmentPatient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment. | Other | 3 |
| Quality of LifeThe Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire, to analyze the overall quality of life of patients, and Dermatology Life Quality Index (DLQI), to analyze the quality of life of patients, in dermatological terms). | Other | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen-Cilag, S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.